- Device
- Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S261
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2021-12-07
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.9.